Adherence adjustment in the Coronary Drug Project: A call for better per-protocol effect estimates in randomized trials

Clinical Trials

Volumn 13, Issue 4, 2016, Pages 372-378

  Murray, Eleanor J ^a   Hernán, Miguel A ^a,b  

^a HARVARD SCHOOL OF PUBLIC HEALTH   (United States)

^b HARVARD MIT DIVISION OF HEALTH SCIENCES AND TECHNOLOGY   (United States)

Author keywords

adherence; Coronary Drug Project; intention to treat effect; inverse probability weighting; Per protocol effect

Indexed keywords

ANTIARRHYTHMIC AGENT; ANTILIPEMIC AGENT; CLOFIBRATE; CONJUGATED ESTROGEN; DEXTROTHYROXINE; DIURETIC AGENT; INSULIN; NICOTINIC ACID; PLACEBO;

ACUTE HEART FAILURE; AORTA DISSECTION; ARTICLE; BRAIN ISCHEMIA; CARDIOVASCULAR RISK; CLINICAL PROTOCOL; CONCEPT FORMATION; CONFIDENCE INTERVAL; CONGESTIVE HEART FAILURE; CORONARY ARTERY EMBOLISM; CORONARY DRUG PROJECT; DRUG MEGADOSE; FOLLOW UP; HEALTH PROGRAM; HEART ARRHYTHMIA; HEART INFARCTION; HIGH RISK PATIENT; HISTORY OF MEDICINE; HUMAN; INTENTION TO TREAT ANALYSIS; ISCHEMIC HEART DISEASE; LOW DRUG DOSE; MEDICAL HISTORY; MORTALITY; NATIONAL HEALTH ORGANIZATION; PATIENT COMPLIANCE; PRESCRIPTION; PRIORITY JOURNAL; PROGNOSIS; RANDOMIZATION; RANDOMIZED CONTROLLED TRIAL (TOPIC); RISK FACTOR; SENSITIVITY ANALYSIS; STANDARD; STATISTICAL MODEL; TREATMENT CONTRAINDICATION; UNSPECIFIED SIDE EFFECT; CORONARY DISEASE; MALE; MEDICATION COMPLIANCE; RISK; STANDARDS; STATISTICAL ANALYSIS; TREATMENT OUTCOME;

CORONARY DISEASE; DATA INTERPRETATION, STATISTICAL; HUMANS; INTENTION TO TREAT ANALYSIS; LOGISTIC MODELS; MALE; MEDICATION ADHERENCE; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RISK; TREATMENT OUTCOME;

EID: 84979010123     PISSN: 17407745     EISSN: 17407753     Source Type: Journal    
DOI: 10.1177/1740774516634335     Document Type: Article

References (19)

1. Gupta SK., Intention-to-treat concept: a review. Perspect Clin Res 2011; 2: 109-112.
2. Hernán MA, Hernandez-Diaz S., Beyond the intention-to-treat in comparative effectiveness research. Clin Trials 2012; 9: 48-55.
3. Hernán MA, Hernandez-Diaz S, Robins JM., Randomized trials analyzed as observational studies. Ann Intern Med 2013; 159: 560-562.
4. Coronary Drug Project Research Group. Influence of adherence to treatment and response of cholesterol on mortality in the coronary drug project. N Engl J Med 1980; 303: 1038-1041.
5. Mark SD, Robins JM., A method for the analysis of randomized trials with compliance information: an application to the Multiple Risk Factor Intervention Trial. Control Clin Trials 1993; 14: 79-97.
6. Robins JM, Finkelstein DM., Correcting for noncompliance and dependent censoring in an AIDS Clinical Trial with inverse probability of censoring weighted (IPCW) log-rank tests. Biometrics 2000; 56: 779-788.
7. Coronary Drug Project Research Group. The coronary drug project. Design, methods, and baseline results. Circulation 1973; 47: I1-I50.
8. Coronary Drug Project Research Group. Factors influencing long-term prognosis after recovery from myocardial infarction-three-year findings of the coronary drug project. J Chronic Dis 1974; 27: 267-285.
9. Coronary Drug Project Research Group. Clofibrate and niacin in coronary heart disease. JAMA 1975; 231: 360-381.
10. Coronary Drug Project Research Group. The Coronary Drug Project. Findings leading to discontinuation of the 2.5-mg day estrogen group. JAMA 1973; 226: 652-657.
11. Coronary Drug Project Research Group. The Coronary Drug Project. Findings leading to further modifications of its protocol with respect to dextrothyroxine. JAMA 1972; 220: 996-1008.
12. The Coronary Drug Project. Initial findings leading to modifications of its research protocol. JAMA 1970; 214: 1303-1313.
13. Robins JM, Hernán MA,. Estimation of the causal effects of time-varying exposures. In: Fitzmaurice G, Davidian M, Verbeke G, et al. (eds). Longitudinal data analysis. New York: Chapman and Hall/CRC Press, 2008, pp. 553-599.
14. Hernán MA, Robins JM., Instruments for causal inference: an epidemiologist's dream? Epidemiology 2006; 17: 360-372.
15. Holme O, Loberg M, Kalager M, et al. Effect of flexible sigmoidoscopy screening on colorectal cancer incidence and mortality: a randomized clinical trial. JAMA 2014; 312: 606-615.
16. Robins JM., A new approach to causal inference in mortality studies with sustained exposure periods-application to control of the healthy worker survivor effect. Math Modelling 1986; 7: 1393-1512; Errata in Comput Math Appl 1987; 14: 917-921.
17. Little RJ, D'Agostino R, Cohen ML, et al. The prevention and treatment of missing data in clinical trials. N Engl J Med 2012; 367: 1355-1360.
18. Eapen ZJ, Lauer MS, Temple RJ., The imperative of overcoming barriers to the conduct of large, simple trials. JAMA 2014; 311: 1397-1398.
19. US Food and Drug Administration. Guidance for industry: determining the extent of safety data collection needed in late stage premarket and postapproval clinical investigations (draft guidance)., http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM291158.pdf (2012,. accessed 16 November 2015)